NCT06416826撤回不适用
An Investigation of the Effects of Rhythmic Sensory Stimulation on Fibromyalgia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- change in inflammatory cytokine levels
研究概览
简要总结
The aim of this project is to further examine the effectiveness of Rhythmic Sensory Stimulation (RSS) with low-frequency sounds and somatosensory stimulation as a complementary therapy for fibromyalgia, and to investigate potential mechanisms underlying the effects of RSS on chronic pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients with clinical diagnosis of fibromyalgia
- •able to read and write English adequately
- •have satisfactory hearing bilaterally (self-reported)
- •have the ability to operate the supplied device
排除标准
- •acute and active inflammatory conditions (e.g., rheumatoid arthritis, osteoarthritis, autoimmune disease)
- •medical or psychiatric illness
- •history of psychosis, epilepsy, seizures
- •pregnancy or breast feeding
- •hemorrhaging or active bleeding
- •thrombosis, angina pectoris
- •heart disease, such as hypotension, arrhythmia, pacemaker
- •substance abuse (harmful or hazardous use of psychoactive subtances, including alcohol and illicit drugs) in the last year
- •suffering from a recently prolapsed vertebral disc
- •recovering from a recent accident with back or neck injury.
结局指标
主要结局
change in inflammatory cytokine levels
时间窗: baseline, 1 month, 2 months
The investigator will use a multiplex enzyme-linked immunosorbent assay (ELISA) to asses inflammatory cytokines in fibromyalgia.
次要结局
- change in EEG brain activity(baseline, 1 month, 2 months)
- change in pain severity(baseline, 1 month, 2 months)
研究者
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